Methods, Systems and Devices for Treating Glaucoma

ABSTRACT

A system is provided including an elongate needle body and an aqueous humor drainage device. The drainage device includes an elongated tube that is operatively coupled to a proximal end of the needle body. Methods for the implantation of the aqueous humor drainage device in the eye are provided. A system including an elongate needle body and drainage device is also provided for draining other body cavities.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/511,802, filed on Oct. 10, 2014, which claims priority from U.S.Provisional Patent Appl. No. 61/908,657, filed on Nov. 25, 2013, both ofwhich are hereby incorporated herein by reference in their entireties.

BACKGROUND

1. Technical Field

The present disclosure relates to the treatment of glaucoma. Moreparticularly, the present disclosure relates to medical devices andmethods for creating a drainage pathway to divert aqueous humor out ofthe anterior chamber of the eye such that pressure within the eye isreduced.

2. State of the Art

Glaucoma, a progressive ocular disease that manifests itself throughelevated intraocular pressure (“IOP”), is one of the leading causes ofpreventable blindness. When the pressure in the eye remains sufficientlyhigh for a long enough period of time, blindness or total vision lossmay occur. If properly treated, the pressure within a glaucomic eye maybe reduced and the possibility of blindness may be averted.

The anatomy of the eye is described with reference to FIG. 1. The eye 10includes an iris 12, which is a colored circular muscle that controlsthe size of the pupil 21, which is an opening located in the center ofthe iris 12. By adjusting the size of the pupil 21, the amount of lightthat is allowed to enter the eye can be adjusted in response to lightconditions. A cornea 14, which is a transparent external surface, coversthe pupil 21 and the iris 12. The area of the eye above the lens 22 andunder the cornea 14 comprises the anterior chamber 16.

The sclera 28, which is the white of the eye, is a tough outer membranethat covers the entire eye 10, except for the portion of the eye 10 thatis covered by the cornea 14. The area or junction where the cornea 14merges into the sclera 28 is known as the limbus 25. A portion of thesclera 28 is covered by a thin tissue called the Tenon's membrane (alsocalled the Tenons Capsule) 34, which envelopes the bulb of the eye 10from the optic nerve (not shown) to the ciliary body 18 of the eye 10.The conjunctiva 36 lines the inside of the eyelids (not shown) andoverlies the Tenon's membrane 34 and the sclera 28.

The trabecular meshwork 24 is a wedge-shaped structure composed ofcollagen beams arranged in a three-dimensional sieve-like structure. Thebeams are lined with a monolayer of cells called trabecular cells. Thespaces between the collagen beams are filled with an extracellularsubstance that is produced by the trabecular cells. These cells alsoproduce enzymes that degrade the extracellular material. The trabecularmeshwork 24 and the Schlemm's canal 26 are located at or near the angle30, which is the angle formed at the vertex of the iris 12 and thecornea 14. The outer wall of the trabecular meshwork 24 coincides withthe inner wall of Schlemm's canal 26.

Schlemm's canal 26 is a tube-like structure that runs around thecircumference of the cornea 14. In human adults, Schlemm's canal 26 isbelieved to be divided by septa into a series of autonomous, dead-endcanals. Aqueous humor travels through the spaces between the trabecularbeams of the trabecular meshwork 24, into Schlemm's canal 26, andthrough a series of collecting channels that drain from Schlemm's canal26 and into the episcleral venous system (not shown).

The anterior chamber 16, which is the space between the iris 12 and thecornea 14, contains a clear fluid called aqueous humor, which isessential for the proper functioning of the eye. Aqueous humor is formedby the ciliary body 18 which is adjacent to the posterior chamber 20 ofthe eye 10. The aqueous humor, which is made at a fairly constant rate,passes around the lens 22, through the pupil 21 in the iris 12 and intothe anterior chamber 16. The aqueous humor naturally drains out of theanterior chamber 14 primarily through the trabecular meshwork 24 andSchlemm's canal 26.

In a normal patient, aqueous humor production is equal to aqueous humoroutflow and intraocular pressure remains fairly constant, typically inthe 8 to 18 mmHg range. If the production of aqueous humor is notbalanced by its proper drainage, the aqueous humor will build up to ahigh level of intraocular pressure (or IOP) and cause glaucoma.

Various devices have been designed to treat glaucoma by alleviating theIOP within the eye. Examples of such devices may be found in U.S. Pat.Nos. 7,431,709; 7,594,899; 7,837,644; and U.S. Pat. Pub. No.2013/0184631, the contents of each of which are incorporated herein intheir entireties.

One such device for treating glaucoma will now be described withreference to FIGS. 1 and 2. A drainage implantation device 100 includesa tube 102 having a lumen 104 extending lengthwise through the tube 102,and a protrusion or fin 106 extending radially outward from the exteriorof the tube 102 as shown in FIG. 2. The fin 106 is configured to preventthe tube 102 from migrating and to prevent the leakage of aqueous humorfrom around the tube 102 (i.e., peri-annular leakage) once the device100 is implanted in a patient's eye as shown in FIG. 2. The tube 102 hasan inlet end 108 disposed opposite an exit end 110. During implantation,the inlet end 108 is positioned within the anterior chamber 16 of theeye, and the exit end 110 is positioned within a space (or pouch) 114that is formed primarily between Tenon's membrane 34 and the sclera 28by physical dissection of the conjunctiva 36 and Tenon's membrane fromthe sclera 28 with scissors as evident from FIG. 2. The tube 102 extendsthrough a needle tract 116 through the sclera 28 leading to the anteriorchamber 16. The needle tract 116 may be formed from a 25 gauge (G)needle (which is approximately 0.020″ or 0.51 mm in diameter). The inletend 108 of the tuber 102 can have a diameter that is approximately0.013″ or 0.33 mm, which is smaller than the diameter of the needle,which facilitates maneuvering of the inlet end 108 through the needletract 116 into the anterior chamber 16. The fin 106 has a diameter thanis larger than the diameter of the needle and thus larger than theneedle tract 116. In this configuration, the fin 106 may be wedged intoscleral tissue of the needle tract 116 and act as a stopper where thescleral tissue seals against the exterior surface of the fin 106 andthus prevent peri-annular leakage. Preventing such uncontrolled leakageof aqueous humor out of the anterior chamber 16 is desirable becausehypotony (very low IOP) may otherwise result, thereby damaging the eye.

The device 100 may be delivered to the implantation site via a hollowneedle. To reduce the possibility of damaging the eye from the insertionof the needle therethrough, it is desirable that the needle be as narrowas possible. However, since the device 100 is to translate through theneedle, the needle must necessarily have a greater diameter than that ofthe device 100. Often, such needles have incorporated slots, extendingalong the length of the needle to accommodate the fin 106 of the tube102 of the device 100 as the tube 102 translates through a lumenextending lengthwise through the needle.

Unfortunately, the use of a slotted, hollow needle may present a fewnoteworthy challenges and difficulties. For example, a slotted needlemay not penetrate the sclera 28 of the eye 10 as easily as a needle thatdoes not have such a slot. In particular, the missing section of theslotted needle may impede the insertion of the needle through the sclera28. Therefore, the force necessary to penetrate the sclera 28 may begreater when using a slotted needle as compared to a needle that doesnot have such a slot. Since it is desirable that the forces required toinsert the needle through the sclera be as small as possible such thatthe possibility of trauma to the eye is kept to a minimum, the use of aslotted needle poses a challenge. Another challenge may be translatingthe implant, e.g., device 100, to the implantation site as it may bedifficult to push a relatively soft tube through a hollow needle becausethe soft tube may expand sufficiently to become jammed in the hollowspace of the needle.

SUMMARY

Disclosed herein are systems, devices, and methods for the treatment ofocular pressure.

In an embodiment, a system for the treatment of ocular pressure mayinclude a needle device and an aqueous humor drainage device. The needledevice may include an elongate needle body that has a sharp distal endand a proximal end. The needle may have a configuration or shape that isstraight or curved, and may have a gauge (or diameter) that is between30 G and 22 G inclusive (a smaller gauge number corresponding to alarger sized diameter). The aqueous humor drainage device may include anelongate tube with two opposed ends. One end of the tube may beoperatively coupled to the proximal end of the needle body. The tube canbe flexible and formed from an elastomeric polymer material. The tubecan have an outer diameter that is at least as large as (or greaterthan) the maximum diameter of the needle body or preferably, the tubecan have an outer diameter that is at least as large as (or greaterthan) the maximum diameter of the needle passageway formed by insertingthe needle through the tissue of the eye. In one embodiment, the tubecan have an outer diameter that is between 100 to 600 μm.

The aqueous humor drainage device can also include one or moreprotrusions that extend radially outward from the exterior surface ofthe intermediate portion of the tube. Such protrusion(s) can be bulbousin shape or simple flares or bumps in the tube, if desired. Theprotrusion(s) can be either symmetrical or non-symmetrical around theaxis of the tube. Such protrusion(s) can function to aid in fixing theposition of the aqueous humor drainage device in the preferred locationin the eye. In addition, the tube can include a visual indicator (suchas a mark) that indicates a proper place where the drainage tube shouldbe placed, cut or otherwise trimmed, if needed.

The aqueous humor drainage device may be formed from a variety ofmaterials. In an embodiment, the tube is formed from a flexibleelastomeric polymer material that is capable of bending and assuming thecurvature of the eye when implanted therein. Furthermore, the aqueoushumor drainage device may be formed from a material that is bio-stableor not bio-reactive. For example, the aqueous humor drainage device maybe formed from a synthetic thermoplastic polymer such as a polyolefin,e.g., poly(styrene-block-isobutylene-block-styrene) (SIBS).

In another embodiment, a method for the treatment or prevention ofglaucoma may include providing a system that includes a needle deviceand an aqueous humor drainage device. The needle device may include anelongate needle body that has a sharp distal end and a proximal end. Theaqueous humor drainage device may include an elongate flexible tube withopposed first and second ends. The first end of the tube may beoperatively coupled to the proximal end of the needle body. The outerdiameter of the tube may be at least as great as the maximum diameter ofthe needle body. The method may further include inserting the sharpdistal end of the needle body through an entrance site in eye tissue toform tissue passageways leading to and from the anterior chamber of theeye, and pushing the needle body through such tissue passageways suchthat the sharp distal end of the needle body exits from an exit site oftissue spaced from the entrance site and extends beyond the exit site.The exposed portion of the needle body that extends beyond the exit sitecan be grasped and pulled such that the needle body and tube are pulledthrough the tissue passageways with at least the first end of the tubethat is coupled to the proximal end of the needle body extending beyondthe exit site of the needle. A portion of the tube adjacent the firstend that extends beyond the exit site is then decoupled from theproximal end of the needle body, for example by cutting the first endportion of the drainage tube at a desired location spaced from theproximal end of the needle body. A drainage bleb (e.g., a blister-likespace) can be defined by eye tissue near either the exit site or theentrance site of the needle. For example, the drainage bleb can bedefined between the conjunctiva/Tenon's membrane and the sclera over alocalized portion of the eye tissue adjacent the exit site or theentrance site. In one embodiment, the drainage bleb is defined by eyetissue near the exit site, and the first end portion of the tube thatextends beyond the exit site is positioned such that it is positionedinside the drainage bleb, and the opposed second end of the tube ispositioned inside the anterior chamber of the eye. In anotherembodiment, the drainage bleb is defined by eye tissue near the entrancesite, and the first end portion of the drainage tube is positionedinside the anterior chamber of the eye, and the opposed second end ofthe tube that extends beyond the entrance site is positioned inside thedrainage bleb. In either configuration, the tube is positioned such thatit provides fluid communication between the anterior chamber of the eyeand the drainage bleb to allow for aqueous humor to drain from theanterior chamber of the eye through the tube into the drainage bleb.

Various approaches for implanting the aqueous humor drainage device aredisclosed. In one embodiment, referred to herein as an ab internoapproach, the distal end of the needle body is inserted into an entrancesite at the cornea near the limbus. The needle body is advanced throughthe cornea and into the anterior chamber, where it is advanced throughthe anterior chamber under the cornea until the distal end hits theangle of the eye. The needle body is advanced further through the angleinto the sclera below the limbus. The needle body is further maneuveredthrough the sclera below the limbus where its distal tip emerges at anexit site spaced from the entrance site. The needle body is pushedfurther such that the distal end of the needle body extends beyond theexit site to expose a distal portion of the needle body adjacent thedistal end. The exposed distal portion of the needle body that extendsbeyond the exit site can be grasped and pulled (for example, with aneedle clamp) such that the needle body and tube are pulled through thetissue passageways defined by the needle body with at least the firstend of the tube that is coupled to the proximal end of the needle bodyextending beyond the exit site. The opposed second end of the tube ispositioned inside the anterior chamber of the eye. The drainage bleb isdefined by eye tissue near the exit site. The first end portion of thetube that extends beyond the exit site of the needle is then decoupledfrom the proximal end of the needle and possibly trimmed if need be. Thefirst end portion of the tube is then positioned such that the end ofthe tube that extends beyond the exit site is positioned inside thedrainage bleb. In this configuration, the tube is positioned such thatit provides fluid communication between the anterior chamber of the eyeand the drainage bleb to allow for aqueous humor to drain from theanterior chamber of the eye through the tube into the drainage bleb.

In another embodiment, referred to herein as an ab externo approach, thedistal end of the needle body is inserted into an entrance site in theconjunctiva near the limbus (or in the sclera near the limbus in theevent that the conjunctiva is pulled away from the sclera at theentrance site). The needle body is then pushed such that its distal endadvances through the sclera under the limbus until its distal end entersthe anterior chamber at or near the angle of the eye. The needle body isfurther advanced through the anterior chamber of the eye such that itpierces the cornea and emerges at an exit site in the cornea spaced fromthe entrance site. The needle body is pushed further such that thedistal end of the needle body extends beyond the exit site to expose adistal portion of the needle body adjacent the distal end. The exposeddistal portion of the needle body that extends beyond the exit site canbe grasped and pulled (for example, with a needle clamp) such that theneedle body and tube are pulled through the tissue passageways definedby the needle body with at least the first end of the tube that iscoupled to the proximal end of the needle extending beyond the exitsite. The first end portion of the tube that extends beyond the exitsite is then decoupled from the proximal end of the needle. The drainagebleb is defined by eye tissue near the entrance site of the needle. Theopposed second end of tube that extends beyond the entrance site can begrasped and pulled such that the opposed first end portion of the tubeis positioned inside the anterior chamber of the eye. The second end oftube that extends beyond the entrance site can be trimmed, if necessary,and positioned inside the drainage bleb. In this configuration, the tubeis positioned such that it provides fluid communication between theanterior chamber of the eye and the drainage bleb to allow for aqueoushumor to drain from the anterior chamber of the eye through the tubeinto the drainage bleb.

In a still further embodiment, a medicant may be injected or applied tothe eye to reduce the possibility of complications from the procedure.The medicant may include, for example, an antiproliferative orantimetabolite agent, e.g., mitomycin C, 5-fluorouracil, etc. Themedicant may also include other agents such as lidocaine, epinephrine,steroids, etc.

The entrance site (and possibly parts of the tissue passageways leadinginto the anterior chamber of the eye) can be formed by the needle bodyor be an incision that was formed in the eye for another procedure, suchas an incision for removal of a cataractous lens for traditionalphacoemulsification of the natural crystalline lens of the eye.

These and other aspects of the present disclosure are more fullydescribed hereinbelow with reference to accompanying figures in whichthe same reference numerals refer to like or similar elements.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prior art aqueous humor drainagedevice.

FIG. 2 is an illustration showing anatomic details of the human eye withthe prior art aqueous humor drainage device of FIG. 1 implanted therein.

FIG. 3A is a perspective view of a first embodiment of an aqueous humordrainage system including a drainage implant tube and a straight needle.

FIG. 3B is a perspective view of a second embodiment of an aqueous humordrainage system including an aqueous humor drainage implant tube and acurved needle.

FIG. 3C is a perspective view of a third embodiment of an aqueous humordrainage system including a drainage implant tube with a protrusion anda straight needle.

FIG. 3D is a perspective view of a fourth embodiment of an aqueous humordrainage system including a drainage implant tube with a plurality ofprotrusions and a straight needle.

FIG. 3E is a perspective view of a fifth embodiment of an aqueous humordrainage system including an aqueous humor drainage implant tube and acurved needle.

FIGS. 4A-4D are perspective views illustrating a first embodiment of amethod using the aqueous humor drainage system of FIG. 3A for theimplantation of an aqueous humor drainage implant tube within an eye.

FIGS. 5A-5D are perspective views illustrating a second embodiment of amethod using the aqueous humor drainage system of FIG. 3A for theimplantation of an aqueous humor drainage implant tube within an eye.

FIGS. 6A-6D are perspective views illustrating a third embodiment of amethod using the aqueous humor drainage system of FIG. 3B for theimplantation of an aqueous humor drainage implant tube within an eye.

FIG. 7 is a perspective view illustrating the aqueous humor drainageimplant tube of FIG. 3D within an eye.

DETAILED DESCRIPTION

As used herein, the term “distal” is generally defined as in thedirection of the eye of the patient, or away from a user of the system,apparatus, and/or device. Conversely, “proximal” generally means in thedirection away from the eye of the patient or toward the user of thesystem, apparatus, or device. As used herein, the word “diameter” refersto the greatest diameter or width of an object along a length thereof,and does not necessarily mean that the object being referred to has across-section that is a circle (e.g., the object may have across-section that is generally circular or oval-shaped).

Embodiments of an aqueous humor drainage system for the treatment ofglaucoma are described herein with reference to FIGS. 3A and 3B. Asshown in FIG. 3A, an aqueous humor drainage system 200A may include anaqueous humor drainage device 201 including an aqueous humor drainagetube (or “drainage tube) 202, and may also include a needle devicedefined by an elongate needle body 204 operatively coupled to thedrainage tube 202. For example, one end 203 of the drainage tube 202 maybe operatively coupled to a proximal end 206 of the needle body 204 byan adhesive, a swagged fitting, a crimping, a whipping, or combinationsthereof. The transition of the needle body 204 to the drainage tube 202can be abrupt or the end of the drainage tube 202 that is coupled to theproximal end 206 of the needle body 204 can possibly be tapered toprovide a tapered transition that facilitates smooth pull-through. Thedrainage tube 202 can also be molded around the filament of aconventional suture that is coupled to the proximal end 206 of theneedle body 204. The needle body 204 has a sharp distal tip 208. Theneedle body 204 is configured to lead the drainage tube 202 throughtissue passageways through eye tissue, which may be formed by thetranslation of the needle body 204 through the eye tissue toward animplantation site within the eye. The drainage tube 202 may be severableor capable of being cut such that the needle body 204 may be uncoupledfrom the drainage tube 202, wherein the needle body 204 may be discardedonce the drainage tube 202 is positioned at a desired location. Theneedle body 204 may have a sufficiently short length such that it may beused in areas around the cornea 14 without interfering with the foreheador nose of the patient as may occur if a long, rigid inserter wereutilized for the implantation of the drainage tube 202 in the eye 10.

The drainage tube 202 may be configured to be implanted within the eyeto divert aqueous humor away from the anterior chamber 16 of the eye 10.The drainage tube 202 may have generally tubular configuration. Inparticular, the drainage tube 202 may have a generally tubular shapehaving an elongate generally cylindrical shape, and may include a lumen207 extending along its length through which fluid may pass. Thedrainage tube 202 may have an outer diameter d_(T) that is between 100and 700 μm, inclusive, and may preferably be between 200 and 500 μm,inclusive. The lumen 207 may have a diameter d_(L) that is between 30and 200 μm, inclusive, and may preferably be between 40 and 120 μm,inclusive. The drainage tube 202 may have an overall length L that isbetween 1 and 30 mm, inclusive, and may be trimmed in situ to a desiredlength that may be between 4 and 15 mm.

The needle body 204 may have an elongate, generally cylindricalconfiguration or shape, and may be generally straight as shown in FIG.3A. The needle body 204 may also include a tapered or pointed distal end208 that may facilitate puncturing and insertion of the needle body 204through eye tissue without creating an opening that is larger than thegauge of the needle body 204. The interior (not shown) of the needle 204may be solid or hollow. The needle body 204 may be formed from anyconventional needle material including, but not limited to, a metal,such as stainless steel, chrome plated steel, titanium, etc.

The needle body 204 may be generally straight, as shown in FIG. 3A.However, the needle body may have any shape or configuration thatfacilitates the implantation of the drainage tube 202. In FIG. 3B, anaqueous humor drainage system 200B is shown that is substantiallysimilar to the system 200A except in the ways that will now bedescribed. In particular, the system 200B includes needle body 205 thatis generally curved. It is to be understood, that needle bodies havingother shapes or configurations may be incorporated into the systems 200Aand 200B. For example, a needle body having a variety of shapes, forexample, multiple curves, may replace the needle body 204 or 205 of thesystems 200A and 200B, respectively.

Each of the needle bodies 204 and 205 of the systems 200A and 200B,respectively, may have a maximal outer diameter d_(N) that is relativelysmaller than the exterior diameter d_(T) of the drainage tube 202. Inone embodiment, the maximum exterior diameter d_(N) of the needle body204 or 205 may have a gauge that ranges from 30 G (approximately 0.0122″or 0.3112 mm) to 22 G (approximately 0.02825″ or 0.7176 mm). The ratioof outer diameter d_(N) of the drainage tube 204 to the outer diameterd_(N) of the needle body may be in the range of 1 to 3, and morepreferably in the range of 1.1 to 1.8.

The sharp or distal end 208 of needle body 204 of system 200A or needlebody 205 of system 200B may include bevels (not shown) that are capableof cutting a hole through tissue as well as dilating tissue. Moreover, ahole that is formed in tissue as a result of the needle body beinginserted through the tissue may correspond to or equal the gauge orthickness of the needle body. When the needle body is retracted from thetissue tract (or tissue passage) which it has formed, the diameter ofthe tissue tract may shrink. For example, if the needle body is 25 G indiameter, the hole when the needle body is in place may be 25 G.However, upon retraction of the needle body, the tissue tract, which isformed by the insertion of the needle body through the tissue, mayshrink to about 27 G. The extent of the shrinkage may correspond to thesharpness and geometry of the distal end of the needle body.Accordingly, the diameter d_(T) of the drainage tube 202 may beapproximately the same size or somewhat larger than the diameter d_(N)to effectively fill and lodge within the tissue tract to prevent orinhibit peri-annular leakage around the drainage tube 202 and migrationof the drainage tube 202 from within the tissue tract formed by theneedle body. Moreover, the drainage tube 202 may be formed from acompressible or semi-compressible material such that the drainage tube202 becomes elongated in length with a reduced outer diameter as it ispulled through the tissue tract and is biased to return toward itsnatural length and outer diameter where there is no pulling forcesapplied to the drainage tube 202. In this case, when the pulling of thedrainage tube 202 is ceased with the drainage tube 202 located in thetissue tract, the drainage tube 202 can relax back toward its naturaloriginal diameter and lodge in the tissue tract thereby preventingperi-annular leakage as well as preventing migration of the drainagetube 202 within the tissue tract. Moreover, the elasticity of the tissueof the tissue tract may accommodate the reception of a slightly largersized diameter tube 202 such that the drainage tube 202 is receivedsnuggly therein.

As shown in FIGS. 3C and 3D, one or more protrusions 211 can extendradially outward from the exterior of the drainage tube 202 at anintermediate position offset between the opposed ends of the drainagetube. The embodiment of FIG. 3C includes one protrusion 211. Theembodiment of FIG. 3D includes two protrusions 211A and 211B that arespaced apart from one another along the length of the drainage tube 202.The protrusion(s) 211 can be bulbous in shape if desired. Suchprotrusion(s) can function to aid in positioning and fixing the drainagetube 202 in the preferred location in the eye. In addition, the drainagetube 202 can include a visual indicator (such as a mark 213 as shown inFIGS. 3C and 3D) that indicates a proper place where the drainage tube202 should be cut or severed or decoupled from the needle and/ortrimmed, if needed.

FIG. 3E shows an aqueous humor drainage system 200C that is similar tothe system 200B with a curved needle body 205. The curved needle body205 has a triangular cross-section whose apex cutting edge is located onthe outside of the needle body curvature. The proximal end 206 of theneedle body 205 is hollow to define a cavity that receives the end 203of the drainage tube 202. The outer diameter of the end 203 of thedrainage tube 202 is less than inner diameter of the hollow cavity ofthe proximal end 206 of the needle body 205. Adhesive can be applied tothe end 203 of the drainage tube 202 before it is inserted into thehollow cavity of the proximal end 206 of the needle body 205, and thenthe adhesive can be allowed to cure to operably couple the end 203 ofthe drainage tube 202 to the proximal end 206 of the needle body 205.Alternatively, the proximal end 206 of the needle body 205 can employ aswagged fitting, a crimping, a whipping, combinations thereof or othersuitable fastening mechanism that operably couples the end 203 of thedrainage tube 202 to the proximal end 206 of the needle body 205. Thedrainage tube 202 of the embodiment of FIG. 3E includes two anchorsections 211A′ and 211B′ that are spaced apart from one another onopposite ends of the drainage tube 202. The anchor sections 211A′ and211B′ each have maximum outer diameter d_(A) that is greater than theouter diameter d_(T) of the intermediate tube section that extendsbetween the two anchor sections 211A′ and 211B′ as shown. The end of theanchor section 211A′ that is located opposite the free end of thedrainage tube 202 (and thus closer to the proximal end 206 of the needlebody 205) can have a surface 213A with a tapered profile that extendsradially outward while tapering away from the end 203 of the drainagetube 202. The end of the anchor section 211B′ that is located adjacentthe end 203 of the drainage tube (and near the proximal end 206 of theneedle body 205) can have a surface 213B with a tapered profile thatextends radially outward while tapering away from the end 203 of thedrainage tube 202. The tapered surfaces 213A and 213B of the anchorsections 211A′ and 211B′ can function to aid in reducing resistancewhile pulling the drainage tube through the needle tract defined by theneedle body 205. The anchor sections 211A′ and 211B′ themselves canfunction to aid in positioning and fixing the drainage tube 202 in thepreferred location in the eye in the same manner described herein withrespect to the protrusion(s) of the embodiments of FIGS. 3C and 3D.

The aqueous humor drainage device (tube) as described herein may beformed from a material that is capable of bending and assuming thecurvature of the eye once implanted therein. Furthermore, the materialforming the aqueous humor drainage device (tube) is preferablyrelatively bio-inert such that, after implantation, the production ofinflammation and fibrosis at or around the implantation site is minimal.In one embodiment, the aqueous humor drainage device may be formed of abio-stable material, e.g., SIBS(poly(styrene-block-isobutylene-block-styrene). The use of suchmaterials may reduce the possibility that the lumen 207 of the drainagetube 202 may become obstructed over time following its implantationwithin the eye.

In other embodiments, the aqueous humor drainage device (tube) may beformed of a synthetic thermoplastic polymer including but not limited topolyolefin, e.g., SIBS, polyethylene, polypropylene, SEBS(styrene-ethylene/butylene-styrene), etc. Other materials that may formthe aqueous humor drainage device 201 may include polyurethanes, such aspolyetherurethanes, polycarbonate urethanes, copolymers of polyurethanewith silicone-diols, polyisobutylene-diols, polyfluoro-diols, etc. Theaqueous humor drainage device 201 may also be formed of fluropolymers,for example, polytetrafluoroethylene (PTFE), fluorinated ethylenepropylene (FEP), polyvinylidene fluoride or polyvinylidene diflouride(PVDF), etc. Other more rigid polymers that can be pre-shaped, such aspolymide, polysulfone, etc., may be used to form the aqueous humordrainage device (tube). Still other materials that may be used to formthe aqueous humor drainage device (tube) include biological polymerssuch as collagen, elastin, gelatin, polysaccharides, etc. The aqueoushumor drainage device (tube) can be formed by extrusion molding of thesynthetic thermoplastic polymer. Other suitable thermoplastic formingmethodologies can also be used such as injection molding, insertmolding, solvent casting, etc.

While it is desirable that the lumen 207 of the drainage tube 202 befree of tissue ingrowth that may block or obstruct the flow of fluidtherethrough, an exterior or outer surface of the drainage tube 202 maybe configured to facilitate tissue ingrowth such that the migration orrelative motion between the tissue bed and the drainage tube 202 isprevented, thereby facilitating permanent anchoring of the drainage tube202 at the implantation site after its implantation. It may also beadvantageous in certain embodiments to have the wall of the tubefenestrated to provide multiple inflow and outflow paths to and from thelumen in the event the ends of the lumen become occluded.

Prior to the procedures for implanting the aqueous humor drainage device201, which are described below with reference to FIGS. 4A to 7, a fluid,such as a viscoelastic fluid, may be pumped into the anterior chamber 16of the eye 10 to create an enlarged space for the reception of theaqueous drainage system therethrough. The viscoelastic fluid may beremoved from the eye by aspiration at the end of the procedure.Moreover, other fluids such as mitomycin C may be injected under theconjunctiva/Tenons to create a hydrated area that functions as alocalized drainage bled. Note that this localized drainage bled isformed in a different manner that physical dissection of the conjunctiva36 and the Tenon's membrane 34 of the eye 10 from the sclera 28 asdescribed above with reference to FIGS. 1 and 2. The creation of thedrainage bleb can involve swabbing or milking the tissue following theinjection to press the raised area toward the limbus of the eye. Theaqueous humor drainage device 201 may be implanted in fluidcommunication with the drainage bleb such that aqueous humor can bediverted from the anterior chamber 16 into the drainage bleb followingthe implantation of the aqueous humor drainage device 201. The injectionof Mitomycin C may occur at the time of surgery or preferably 30 minutesto several days prior to surgery to allow the Mitomycin C to soak intothe tissue as opposed to forming puddles of Mitomycin C. The reasonpuddles of Mitomycin C are avoided is to prevent it back-flowing throughthe drainage shunt into the anterior chamber which can cause trauma tothe cornea and other organelles of the eye.

With reference to FIGS. 4A-4D, an ab interno approach will now bedescribed that utilizes the aqueous humor drainage system 200A of FIG.3A to implant the aqueous humor drainage device 201. As shown in FIG.4A, the distal end 208 of the needle body 204 may penetrate the cornea14 at entrance site I (or, if done subsequent to cataract surgery, aslit in the clear cornea may already be in place at entrance site I).The drainage bled is formed near the exit site E as described below. Theneedle body 204 may be pushed such it is advanced through the entrancesite I in the cornea 14 into the anterior chamber 16 and then throughthe anterior chamber 16 until the distal tip 208 contacts the angle 30of the eye 10. The needle body 204 is pushed to advance and maneuver theneedle body 204 through the sclera 28 below the limbus 25 such that thedistal tip 208 emerges through the sclera 28 (and/or any overlyingconjunctiva 36) at the exit site E. At this point, the distal end of theneedle body 204 extends beyond the exit site E to expose a distalportion of the needle body 204 adjacent the distal end of the needlebody 204 as shown in FIG. 4B. The exposed distal portion of the needlebody 204 can be grasped and pulled (for example, with a needle clamp(not shown)) such that the needle body 204 and the drainage tube 202 arepulled through the tissue passageways defined by the advancement of theneedle body 204 through the tissue of the eye 10 with at least the end203 of the drainage tube 202 that is coupled to the proximal end of theneedle 204 extending beyond the exit site E as shown in FIG. 4C. Theexposed distal portion of the needle body 204 may be grasped and pulledto pull the drainage tube 202 until a length of the drainage tube 202drops below the cornea 14 and remains in the anterior chamber 16 of theeye, and a portion of the drainage tube 202 extends out from the sclera28 beyond the exit site E. In this configuration, 1 to 3 mm of thedrainage tube 202 can remain in the anterior chamber 16 of the eye.Thereafter, the portion of the drainage tube 202 that extends beyond theexit site E may be severed or cut or otherwise decoupled from the needlebody 204, and the needle body 204 may be discarded while leaving thedrainage tube 202 implanted within the eye 10. The severing or cuttingor decoupling of the drainage tube can occur at a visual indicator (suchas visual indicator 213 shown in FIGS. 3C and 3D). The remaining tail ofthe drainage tube 202 that extends beyond the exit site E can then bepositioned inside the drainage bleb. The unshaded portion of the eye 10in FIGS. 4A-4D illustrate the conjunctiva 36 can be pushed anteriorly,scrunched up, or retracted toward the limbus 25 (moved out of the way)to enable the needle to penetrate the conjunctiva posteriorly (towardsthe head). Penetration posteriorly is preferred as theconjunctiva/Tenons are thicker and will heal quicker with less chance ofleakage as compared to an anterior penetration. Once the needle 204 issevered from the tube 202, the conjunctiva 36 may then be swabbed, movedback, or sutured at or near its initial position such that the exposedend of the drainage tube 202 that extends beyond the exit site E ispositioned inside the drainage bleb and anteriorly from the exit wound.Thereafter, any external opening in the eye, e.g., the entrance site Iformed by the needle 204, may be sealed, for example, by cauterizing,suturing or gluing such an opening. In this configuration, the drainagetube 202 is positioned such that it provides fluid communication betweenthe anterior chamber of the eye and the drainage bleb to allow foraqueous humor to drain from the anterior chamber of the eye through thelumen 207 of the drainage tube 202 into the drainage bleb.

With reference to FIGS. 5A-5D, an ab externo approach will now bedescribed that uses the aqueous humor drainage system 200A of FIG. 3A toimplant the aqueous drainage device 201. In an area near the entrancesite I where the needle body 204 is to be inserted, the conjunctiva 36may be scrunched up or milked anteriorly to enable penetration of theconjunctiva/Tenons through a thicker section to allow for better healingas well as to locate the conjunctiva wound in an area remote from theend of the drainage tube. As shown in FIGS. 5A and 5B, the distal end208 of the needle body 204 may be pushed such that it penetrates throughthe conjunctiva 36 (if not retracted) and the sclera 28 at the entrancesite I. The needle body 204 may be advanced such that the distal tip 208is advanced under the limbus 25 and enters into the anterior chamber 16at or near the angle 30 of the eye and passes through the anteriorchamber 16 under the cornea 14 as shown in FIG. 5B. The distal end 208of the needle body 204 may be advanced further until the distal end 208penetrates and extends out from the cornea 14 at an exit site E in thecornea 14 as shown in FIG. 5C. The needle body 204 is pushed furthersuch that the distal end 208 of the needle body 204 extends beyond theexit site E to expose a distal portion of the needle body 204 adjacentthe distal end 208. The exposed distal portion of the needle body 204that extends beyond the exit site E can be grasped and pulled (forexample, with a needle clamp (not shown)) such that the needle body 204and the drainage tube 202 are pulled through the tissue passagewaysdefined by the advancement of the needle body 204 with at least the end203 of the drainage tube 202 that is coupled to the proximal end of theneedle body 204 extending beyond the exit site E as shown in FIG. 5C.The exit end portion of the drainage tube 202 that extends beyond theexit site E is then severed or cut or decoupled from the proximal end ofthe needle body 204. The severing or cutting or decoupling of thedrainage tube 202 can occur at a visual indicator (such as visualindicator 213 shown in FIGS. 3C and 3D). Thereafter, the needle body 204may be discarded. The drainage bleb is defined by eye tissue near theentrance site I. The opposed free end of drainage tube 202 that extendsbeyond the entrance site I can be grasped and pulled such that theopposed exit end portion of the drainage tube 202 is retracted into aposition inside the anterior chamber 16 under the cornea 14 as shown inFIG. 5D. In this configuration, 1 to 3 mm of the drainage tube 202 canremain in the anterior chamber 16 of the eye. The free end of drainagetube 202 that extends beyond the entrance site I can be trimmed, ifnecessary, and positioned inside the drainage bleb. If the conjunctiva36 was pushed anteriorly, scrunched up, or retracted toward the limbus25, the portion of the conjunctiva the may be returned to its initialposition, for example, by using sutures or may be forced back into itsinitial position or simply relax back to its initial position.Thereafter, any external opening in the eye, e.g., the exit site Eformed by the needle body 204, may be sealed if necessary, for example,by cauterizing, gluing or suturing such an opening. In thisconfiguration, the drainage tube 202 is positioned such that it providesfluid communication between the anterior chamber of the eye and thedrainage bleb to allow for aqueous humor to drain from the anteriorchamber of the eye through the lumen 207 of the drainage tube 202 intothe drainage bleb.

With reference to FIGS. 6A-6D, an ab interno approach will now bedescribed that utilizes the aqueous humor drainage system 200B of FIG.3B to implant the aqueous drainage device 201. As shown in FIG. 6A, thedistal end 208 of the curved needle body 205 may penetrate the cornea 14at entrance site I. Note that the entrance site I may be the clearcorneal incision formed during a cataract surgery procedure. Thedrainage bleb is formed near the exit site E as described below. Theneedle body 205 may be maneuvered such it is advanced through theentrance site I in the cornea 14 into the anterior chamber 16 as shownin FIG. 6B and then through the anterior chamber 16 until the distal tip208 contacts the angle 30 of the eye 10. The needle body 205 ismaneuvered further such that the distal end 208 extends through thesclera 28 below the limbus 25 and then pierces the sclera 28 (and/or anyoverlying conjunctiva 36 or Tenons 34) at the exit site E. At thispoint, the distal end of the needle body 205 extends beyond the exitsite E to expose a distal portion of the needle body 205 adjacent thedistal end of the needle body 205 as shown in FIG. 6C. The exposeddistal portion of the needle body 205 can be grasped and pulled (forexample, with a needle clamp (not shown)) such that the needle body 205and the drainage tube 202 are pulled through the tissue passagewaysdefined by the advancement of the needle body 205 through the tissue ofthe eye 10 with at least the end of the drainage tube 202 that iscoupled to the proximal end of the needle body 205 extending beyond theexit site E. The exposed distal portion of the needle body 205 may bepulled to pull the drainage tube 202 until approximately 1 to 3 mm ofthe drainage tube 202 remains in the anterior chamber 16, and a portionof the drainage tube 202 extends out from the sclera 28 beyond the exitsite E. Thereafter, a portion of the drainage tube 202 that extendsbeyond the exit site E may be severed or cut or decoupled from theneedle body 205, and the needle body 205 may be discarded while leavingthe drainage tube 202 implanted within the eye 10. The severing orcutting or decoupling of the drainage tube 202 can occur at a visualindicator (such as visual indicator 213 shown in FIGS. 3C and 3D). Theexposed end of the drainage tube 202 that extends beyond the exit site Eis then positioned inside the drainage bleb formed near the exit site E.In doing so, the exposed end of the drainage tube may be placed ortucked under the conjunctiva 36 and/or Tenon's membrane 34, and anyconjunctiva 36 that was retracted or bunched up may be restored to itsinitial position. Thereafter, any external opening in the eye, e.g., theentrance site I formed by the needle body 205, may be sealed ifnecessary, for example, by cauterizing, suturing or gluing such anopening. In this configuration, the drainage tube 202 is positioned suchthat it provides fluid communication between the anterior chamber of theeye and the drainage bleb to allow for aqueous humor to drain from theanterior chamber of the eye through the lumen 207 of the drainage tube202 into the drainage bleb.

An ab interno approach can be used in conjunction with the aqueous humordrainage system of FIG. 3E to implant the aqueous humor drainage deviceinto the eye in a manner similar to the ab interno approach that isdiscussed above with reference to FIGS. 6A-6D. Furthermore, an abexterno approach can be used in conjunction with the aqueous humordrainage system of FIGS. 3B and 3E to implant the aqueous humor drainagedevice into the eye in a manner similar to the ab externo approach thatis discussed above with reference to FIGS. 5A-5D.

FIG. 7 shows the aqueous humor drainage tube 202 of FIG. 3D having twoprotrusions 211A and 211B, which is implanted into the eye using the abinterno approach of FIG. 4A-4D (or 6A-6D). The protrusions 211A and 211Bcan aid in positioning and fixating the drainage tube 202 in its desiredposition as shown in FIG. 7. Specifically, the protrusion 211A ispositioned inside the anterior chamber 16 of the eye and can addresistance to the pull force applied to the exit site end of thedrainage tube 202 as the drainage tube 202 is pulled through the tissuetract created by the needle body 204 and the protrusion 211A contactsthe tissue near the angle and the limbus of the eye. Furthermore, thelength offset between the protrusion 211A and the free end of thedrainage tube 202 can be used to ensure the desired length of drainagetube remains in the anterior chamber 16 of the eye. The protrusion 211Bis positioned near the exit site E and can aid in fixation by minimizingmovement of the drainage tube 202 toward the anterior chamber 16 of theeye.

For the ab externo approach of FIGS. 5A-5D, the protrusions 211A and211B can also aid in positioning and fixating the drainage tube 202 inits desired position. In this case, the protrusion 211B is positionedinside the anterior chamber 16 of the eye and can add resistance to thepull force applied to the entrance site end of the drainage tube 202 asthe drainage tube 202 is retracted and the protrusion 211B contacts thetissue near the angle and the limbus of the eye. Furthermore, the lengthoffset between the protrusion 211B and the severed end of the drainagetube 202 can be used to ensure the desired length of drainage tuberemains in the anterior chamber 16 of the eye. The protrusion 211A ispositioned near the entrance site I and can aid in fixation byminimizing movement of the drainage tube 202 toward the anterior chamber16 of the eye which can occur when the patient blinks. Although FIG. 7shows two protrusions, there need only be one protrusion located eitheron the distal or proximal end of the tube 202.

Note that the entrance site (and possibly parts of the tissuepassageways leading into the anterior chamber of the eye) can be formedby the needle body or be an incision that was formed in the eye foranother procedure (such as an incision required to remove thecataractous lens of the patient and to perform the traditionalphacoemulsification procedure). Furthermore, the tract through thesclera can be formed with a conventional needle or knife prior toinsertion of the drainage tube.

In a still further embodiment, the procedure can be performed using amedicant as an adjuvant to the procedure. The medicant may include, forexample, an antiproliferative or antimetabolite agent, e.g., mitomycinC, 5-fluorouracil, etc. The drug can be injected under the conjunctiva36 and Tenon's membrane 34 prior to performing the procedure. The drugcan be sponged into place, eluted from the implant, added after theimplant is in place and/or added in combination with all of the above.In addition, the drug can be injected in place in combination withlidocaine, epinephrine or other drugs such as antibiotics and the like.

There have been described and illustrated herein several embodiments ofdevices, systems, and methods for the treatment of glaucoma. Whileparticular embodiments of the invention have been described, it is notintended that the invention be limited thereto, as it is intended thatthe invention be as broad in scope as the art will allow and that thespecification be read likewise. Thus, while particular systems, devicesand methods have been disclosed, it will be appreciated that otherdevices and methods may fall within the scope and spirit of the presentdisclosure. Specifically, these embodiments need not be restricted toglaucoma nor to the field of ophthalmology. A similar drainage systemcan be used to treat hydrocephalies by shunting from spaces containingcerebral spinal fluid to body cavities at a lesser pressure. Similarly,bursas and the like can be drained with this system. It will thereforebe appreciated by those skilled in the art that yet other modificationscould be made to the provided invention without deviating from itsspirit and scope as claimed.

What is claimed is:
 1. A system for the treatment of ocular pressurecomprising: a needle device and a drainage device, wherein the needledevice includes a needle body having a sharp distal end and a proximalend, and the drainage device includes an elongate tube with opposedfirst and second ends, wherein the first end of the tube is operativelycoupled to the proximal end of the needle body.
 2. A system according toclaim 1, wherein: the proximal end of the needle body defines a cavitythat receives the first end of the tube.
 3. A system according to claim2, wherein: adhesive bonds the proximal end of the needle body to thefirst end of the tube disposed in the cavity of the needle body.
 4. Asystem according to claim 2, wherein: the proximal end of the needlebody surrounds the first end of the tube.
 5. A system according to claim1, wherein: the needle body has at least one of the followingcharacteristics: a straight configuration or curved configuration, and agauge that is between 30 G and 22 G.
 6. A system according to claim 1,wherein: the tube has at least one of the following characteristics: thetube is flexible and formed from an elastomeric polymer material; thetube has an outer diameter that is at least as large as (or greaterthan) the maximum diameter of the needle body, the ratio of the outerdiameter of the tube to the outer diameter of the needle body is in therange of 1 to 3, and more preferably in the range of 1.1 to 1.8, and thetube has an outer diameter that is between 100 μm and 600 μm.
 7. Asystem according to claim 1, wherein: the drainage device includes atleast one element that extends radially outward from the exteriorsurface of an intermediate portion of the tube.
 8. A system according toclaim 7, wherein: the at least one element is bulbous in shape.
 9. Asystem according to claim 7, wherein: the at least one element isconfigured to fixate the drainage device in a tissue tract created bythe needle.
 10. A system according to claim 1, wherein: the drainagedevice is configured to drain aqueous humor from the eye.
 11. A systemaccording to claim 10, wherein the drainage device includes at least oneelement that extends radially outward from the exterior surface of anintermediate portion of the tube, wherein the at least one elementincludes an element that remains in the anterior chamber of the eyeafter implantation of the drainage device into the eye.
 12. A systemaccording to claim 1, wherein: the drainage device further includes avisual indicator that indicates a proper place where the tube should becut or otherwise trimmed.
 13. A system according to claim 1, wherein:the drainage device is be formed from a synthetic thermoplastic polymer(such as a polyolefin, e.g.,poly(styrene-block-isobutylene-block-styrene) (SIBS)).
 14. A systemaccording to claim 1, wherein: the tube is operably coupled to aproximal end of the needle body by at least one of an adhesive, aswagged fitting, a crimping, a whipping, a suture or combinationsthereof.
 15. A system according to claim 1, wherein: the tube isoperably coupled to a proximal end of the needle body by an abrupttransition or tapered transition.
 16. A system according to claim 1,wherein: the tube is formed from a compressible material such that thetube becomes elongated in length with a reduced outer diameter whensubjected to pulling forces that pull the tube through a tissue tractcreated by the needle and that is biased to return toward its naturallength and outer diameter where there is no pulling forces applied tothe tube.
 17. A system according to claim 1, wherein: the material ofthe tube is configured to allow cutting to decouple the tube from theneedle.